```

[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 509 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 509

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
     provisions regarding the composition and labeling of dietary 
                              supplements.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            January 21, 1993

 Mr. Gallegly (for himself, Mr. Inhofe, Mr. Shays, Mr. Cox, Mr. Taylor 
 of North Carolina, Mr. Stump, Mr. Burton of Indiana, Mr. Hansen, Mr. 
 Hunter, Mr. Hastert of Illinois, Mr. Upton, and Mr. Schiff introduced 
 the following bill; which was referred to the Committee on Energy and 
                                Commerce

                            August 23, 1993

Additional sponsors: Mr. Stearns, Mr. Klug, Mr. Emerson, Mr. Manzullo, 
Mr. Hancock, Mr. Armey, Mr. Herger, Mr. Baker of Louisiana, Mr. DeLay, 
  Mr. Thomas of California, Mr. Skeen, Mr. Bartlett of Maryland, Mr. 
 Schaefer, Mr. Gingrich, Mr. Fields of Texas, Mr. Dreier, Mr. Boehner, 
Mr. Fish, Mrs. Thurman, Mr. Hefley, Mr. Goss, Mr. Walsh, Mr. Crane, Mr. 
   Kim, Mr. McKeon, Mr. Doolittle, Mr. Roth, Mr. Hyde, Mr. Smith of 
 Oregon, Mr. Sensenbrenner, Mr. Spence, Mr. Packard, Mr. Calvert, and 
                               Mr. Royce

                            January 5, 1994

   Additional sponsors: Mr. Duncan, Mr. Cunningham, Mr. Dornan, Mr. 
Portman, Mr. Quillen, Mr. Istook, Mr. Thomas of Wyoming, Mr. Camp, Mr. 
 Linder, Mr. Franks of Connecticut, Mr. Petri, Mr. Wolf, Mr. Ravenel, 
         Mr. Rohrabacher, Mr. Archer, Mr. Pombo, and Mr. Crapo

_______________________________________________________________________

                                 A BILL

 
    To amend the Federal Food, Drug, and Cosmetic Act to establish 
     provisions regarding the composition and labeling of dietary 
                              supplements.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Health Freedom Act of 1993''.

SEC. 2. DEFINITIONS.

    (a) Dietary Supplement.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following new paragraph:
    ``(ff) The term `dietary supplement' means an article that--
            ``(1) includes, and is intended to supplement the diet 
        with--
                    ``(A) a vitamin;
                    ``(B) a mineral;
                    ``(C) an herb; or
                    ``(D) another similar nutritional substance, 
                including a concentrate or extract of an item described 
                in clause (A), (B), or (C); and
            ``(2)(A) is intended for ingestion in a form described in 
        paragraph (1)(B)(i) or (2) of section 411(c), or another 
        similar form; or
            ``(B) complies with section 411(c)(1)(B)(ii).''.
    (b) Drug.--Section 201(g)(1) of such Act is amended by adding at 
the end the following: ``A dietary supplement shall not be considered 
to be a drug solely because of the potency of a substance in the 
dietary supplement. A dietary supplement shall not be considered to be 
a drug under clause (B) solely because the labeling or advertising for 
the supplement contains a claim, or provides information, that is 
described in section 413(b) and meets the requirements specified in 
paragraphs (1) and (2) of such section, or that concerns the potency of 
a substance in the supplement.''.
    (c) Food Additive.--Section 201(s) of such Act is amended--
            (1) by redesignating subparagraphs (1) through (5) as 
        clauses (A) through (E), respectively;
            (2) by inserting ``(1)'' after ``(s)''; and
            (3) by adding at the end the following:
    ``(2) A substance in a dietary supplement is not a food additive if 
the substance is identified in the labeling of the dietary supplement 
as a substance provided by the product to supplement the diet.''.

SEC. 3. DIETARY SUPPLEMENTS.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following new section:

``SEC. 413. LABELING AND ADVERTISING OF DIETARY SUPPLEMENTS.

    ``(a) Description.--Notwithstanding any other provision of this 
Act, an article that is a dietary supplement may be described as a 
dietary supplement in labeling or advertising.
    ``(b) Relationship to Disease or Health-Related Condition.--
Notwithstanding any other provision of this Act, labeling or 
advertising for a dietary supplement may include a claim or other 
information that characterizes the relationship of the dietary 
supplement, or of one or more of the substances provided by the dietary 
supplement, or of the absence of one or more of the substances, to a 
disease or health-related condition, if--
            ``(1) such claim or other information is truthful and not 
        misleading; and
            ``(2) there is scientific evidence, whether published or 
        unpublished, that provides a reasonable basis for such claim or 
        other information.
    ``(c) Prohibition on Prior Approval or Regulation.--Notwithstanding 
any other provision of this Act, the Secretary shall not establish any 
requirement that such a claim or other information that meets the 
requirements specified in paragraphs (1) and (2) of subsection (b) 
shall be approved by or conform to a regulation issued by the Secretary 
before the claim or information may be used.
    ``(d) Actions.--
            ``(1) Right of action.--If the Secretary asserts that 
        labeling or advertising for a dietary supplement includes such 
        a claim or other information that fails to comply with 
        paragraph (1) or (2) of subsection (b), whether the Secretary 
        makes the assertion in a warning letter issued by an officer or 
        employee of the Department, or in connection with another 
        action to enforce a provision of this Act, the manufacturer, 
        processor, packer, distributor, or retailer, of the dietary 
        supplement, or other person to whom the assertion is addressed, 
        may--
                    ``(A) bring an action in a United States district 
                court in any appropriate judicial district under 
                section 1391 of title 28, United States Code, to secure 
                a declaratory judgment regarding the validity of the 
                assertion; and
                    ``(B) obtain any other means of judicial review 
                authorized by law.
            ``(2) Inference.--The absence of any action described in 
        subparagraph (A) or (B) in paragraph (1) with respect to an 
        assertion shall not establish any inference that the assertion 
        is valid.''.
    (b) Conforming Amendment.--Section 403(r)(5) of such Act (21 U.S.C. 
343(r)(5)) is amended by striking clause (D).

                                 <all>
```